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1.
J Pers Med ; 14(5)2024 May 17.
Article in English | MEDLINE | ID: mdl-38793122

ABSTRACT

BACKGROUND: The acute coronary syndrome (ACS) continues to be a fundamental indication for revascularization by percutaneous coronary intervention (PCI). Drug-eluting stent (DES) implantation remains a part of contemporary practice but permanent caging of the vascular structure with the metallic stent structure may increase the rate of device-related adverse clinical events. As an alternative to classic metallic DESs, the bioresorbable scaffolds (BRSs) have emerged as a temporary vascular support technology. We evaluated the mid-term outcomes of two generations of bioresorbable scaffolds-Absorb (Abbott-Vascular, Chicago, IL, USA) and Magmaris (Biotronik, Germany)-in patients with non-ST-elevation ACS. METHODS: The study cohort consisted of 193 subjects after Magmaris implantation and 160 patients following Absorb implantation in large-vessel lesions. RESULTS: At 2 years, a significantly lower rate of a primary outcome (cardiac death, myocardial infarction, stent thrombosis) was observed with Magmaris (5.2% vs. 15%; p = 0.002). In addition, we observed a significantly lower rate of MI in the target vessel (2.6% vs. 9.4%; p = 0.009) and a lower rate of scaffold thrombosis (0% vs. 3.7%; p = 0.008). The TLF rate between the two groups was not significantly different. CONCLUSION: Magmaris demonstrated a good safety profile and more favorable clinical outcomes when compared to Absorb in patients with non-ST-elevation ACS.

2.
Diab Vasc Dis Res ; 20(4): 14791641231188705, 2023.
Article in English | MEDLINE | ID: mdl-37439002

ABSTRACT

BACKGROUND: Diabetes type 2 is one of the strongest risk factors affecting coronary artery disease (CAD) and is also a marker of poor short and long-term prognosis in subjects with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) with subsequent drug-eluting stent (DES) implantation. Chronic local vascular inflammation along with endothelial dysfunction is postulated to be the pathophysiological background of unfavorable results. The second generation of metallic magnesium BRS -Magmaris (Biotronik, Berlin, Germany) had been introduced to clinical practice to overcome these limitations. METHODS: We evaluated 2-years clinical outcomes after Magmaris BRS implantation in NSTE-ACS diabetic (n-72) and non-diabetic (n-121) cohorts. RESULTS: No significant differences between diabetic and non-diabetes cohorts were noticed in terms of Primary Outcome (cardiac death, myocardial infarction, stent thrombosis) (8.1% vs 3.3% p = 0.182) and Principal secondary outcome - TLF- target lesion failure (9.5% vs 3.3% p = 0.106) at 2-years follow-up. CONCLUSIONS: 2-years outcome suggests good safety and efficacy of the magnesium BRS (Magmaris) in NSTE- ACS and concomitant DM. Nevertheless, there is a strong need for large multicenter, randomized, prospective studies for a full assessment of this novel device in diabetic patients with ACS.


Subject(s)
Acute Coronary Syndrome , Diabetes Mellitus , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Magnesium/adverse effects , Absorbable Implants , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Inflammation
3.
Cardiol J ; 2022 May 27.
Article in English | MEDLINE | ID: mdl-35621089

ABSTRACT

BACKGROUND: Acute coronary syndrome (ACS) as a clinical manifestation of coronary artery disease (CAD) remains a significant cause of mortality and morbidity, as reported worldwide annually. The second generation of drug-eluting stents (DES) is a gold standard in percutaneous interventions in ACS patients however, permanent caging of the vessel with metallic DES has some drawbacks. Bioresorbable vascular scaffolds (BRS) were designed as a temporal vessel-supporting technology allowing for anatomical and functional restoration. Nevertheless, following the initial encouraging reports, numerous concerns about the safety of BRS occurred. METHODS: In this study, a 1-year performance of 193 patients with magnesium BRS - Magmaris (Biotronik, Berlin, Germany) was evaluated in comparison to 160 patients with polymer BRS - Absorb (Abbott-Vascular, Chicago, USA) in the non-ST-segment elevation-ACS setting. RESULTS: The Magmaris, when compared to Absorb showed a significantly lower rate of primary endpoint (death from cardiac causes, myocardial infarction, stent thrombosis) as well as target lesion failure in 30-day and 1 year follow-up. In the Absorb group, a significantly higher rate of stent thrombosis was observed. CONCLUSIONS: Data from the present study suggests encouraging safety a profile and more favorable clinical outcomes of Magnesium BRS in comparison to the polymer Absorb - BRS.

4.
Kardiol Pol ; 80(3): 302-306, 2022.
Article in English | MEDLINE | ID: mdl-35113993

ABSTRACT

BACKGROUNDS: The data concerning the use of bioresorbable vascular scaffolds (BVS) in coronary bifurcation lesions are limited. AIMS: The objective of the study was to evaluate the early and very long-term clinical outcomes of bifurcation stenting with ABSORB BVS. METHODS: One hundred consecutive patients with coronary bifurcation lesions treated with BVS were included. A total of 124 BVS were implanted. Provisional side branch stenting was performed in 66 patients, distal main stenting in 14 patients, systematic T stenting in 2, and T with minimal protrusion (TAP) in 5 patients. Side branch ostial stenting was performed in additional 12 patients. RESULTS: The procedural success was achieved in 98% of patients. In long-term follow-up, the rate of cardiac death was 4.0%, target vessel myocardial infarction was 5.0%, and target vessel revascularization (TVR) was 11%. The cumulative incidence of definite/probable scaffold thrombosis (ST) was 2% at long-term follow-up. Comparison with the historical drug-eluting stents (DES) group revealed higher mortality and major adverse cardiac events rate in the ABSORB group. CONCLUSIONS: Stenting of coronary bifurcation lesions of low-to-moderate complexity with BVS was feasible with good acute performance and acceptable results. However, the risk of death and major adverse cardiovascular events was higher as compared with DES.


Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Coronary Angiography , Coronary Artery Disease/etiology , Follow-Up Studies , Humans , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Treatment Outcome
5.
Cardiovasc Revasc Med ; 39: 106-113, 2022 06.
Article in English | MEDLINE | ID: mdl-34629285

ABSTRACT

Bioresorbable scaffolds provide transient vessel support without the long-term limitations of permanent metallic drug-eluting stents. The sirolimus-eluting resorbable magnesium scaffold Magmaris is the only CE-marked metallic bioresorbable scaffold and provides short-term lumen support before being completely bioresorbed. To date, clinical trial results have demonstrated low adverse event rates in patients with simple coronary lesions. Seven European centers with large experience in Magmaris implantation, combined efforts in an informal collaboration to evaluate and appraise clinical data currently available regarding the performance of Magmaris in patients presenting with acute coronary syndromes, and to supply user-advice on patient selection and optimal implantation practice.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Percutaneous Coronary Intervention , Absorbable Implants , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/etiology , Acute Coronary Syndrome/therapy , Coronary Artery Disease/etiology , Humans , Magnesium , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Treatment Outcome
6.
J Interv Cardiol ; 2022: 5223317, 2022.
Article in English | MEDLINE | ID: mdl-36605917

ABSTRACT

Background: Percutaneous coronary intervention (PCI) in the acute coronary syndrome (ACS) setting is associated with a greater probability of device failure. The currently ongoing development of new scaffold technologies has concentrated an effort on improving the PCI outcomes, including the use of new biodegradable materials. This pilot study evaluates the performance of a magnesium bioresorbable scaffold (Magmaris, Biotronik, Germany) in comparison to the sirolimus-eluting bioresorbable polymer stents (BP-SES) (Ultimaster, Terumo, Japan) in the NSTE-ACS setting. Methods: The population of this pilot comprised 362 patients assigned to one of two arms (193-Magmaris vs 169-Ultimaster). The data regarding the primary outcome comprised of death from cardiac causes, myocardial infarction, and stent thrombosis, along with target-lesion failure (TLF) and other clinical events was collected in the 1-yearfollow-up. Results: There were no statistically significant differences in clinical outcomes in the short term (30 days) or in the 1-yearfollow-up between both groups. Conclusion: At 12 months, there were no statistically significant differences between the Magmaris and Ultimaster for composed endpoints or the TLF.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Acute Coronary Syndrome/surgery , Magnesium , Absorbable Implants , Pilot Projects , Treatment Outcome , Polymers , Prosthesis Design , Coronary Artery Disease/surgery
7.
Postepy Kardiol Interwencyjnej ; 18(4): 483-495, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36967840

ABSTRACT

Introduction: It has been suggested that infarct-related artery (IRA) atherosclerosis progression after stem cell transcoronary administration might represent a stem-cell mediated adverse effect. Aim: To evaluate, using conventional (quantitative coronary angiography, QCA, intravascular ultrasound - IVUS) and novel (quantitative virtual histology - qVH) tools, evolution of IRA atherosclerosis following transcoronary stem cell transfer. Material and methods: QCA, IVUS, VH-IVUS and qVH were performed in 22 consecutive patients (4 women) aged 59 years (data provided as median) undergoing a distal-to-stent infusion of 2.21 × 106 CD34+CXCR4+ autologous bone marrow cells via a cell delivery-dedicated perfusion catheter at anterior AMI day 7. Imaging was repeated at 12 months. This was a substudy of Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial (NCT00316381). Results: 18.2% subjects showed absence of distal-to-stent angiographic/IVUS atherosclerotic lesion(s) at baseline and no new lesion(s) at 12-months. In the remaining cohort, there were 28 lesions by QCA (32 by IVUS) at baseline and no new lesion(s) at follow-up. Three fibroatheromas evolved (2 to calcified fibroatheroma and 1 to a fibrocalcific lesion); other plaques maintained their stable (low-risk) phenotypes. Diameter stenosis of QCA-identified lesions was 29.5 vs. 26.5% (p = 0.012, baseline vs. 12-months). Gray-scale IVUS showed reduction in area stenosis (33.8 vs. 31.0%, p = 0.004) and plaque burden (66.27 vs. 64.56%, p = 0.009) at 12-months. Peak fibrotic plaque content increased from 70.41% to 75.0% (p = 0.004). qVH peak confluent necrotic core area and minimal fibrous cap thickness remained stable (0.64 vs. 0.59 mm2, p = 0.290, and 0.15 vs. 0.16 mm, p = 0.646). Conclusions: This study, using a range of classic and novel imaging techniques, indicates lack of any stimulatory effect of transcoronary stem cell transfer on coronary atherosclerosis. Whether, and to what extent, a moderate reduction in plaque burden and stenosis severity at 12-months results from optimized pharmacotherapy and/or stem cell transfer requires further elucidation.

8.
Catheter Cardiovasc Interv ; 99(3): 664-673, 2022 02.
Article in English | MEDLINE | ID: mdl-34582631

ABSTRACT

OBJECTIVES: to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly. BACKGROUND: Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited. METHODS: ROCK II is a multicenter, investigator-driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS. RESULTS: A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascular-imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p = 0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found. CONCLUSIONS: Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Vessels/diagnostic imaging , Coronary Vessels/pathology , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Retrospective Studies , Tomography, Optical Coherence/methods , Treatment Outcome , Ultrasonography, Interventional/methods
9.
J Diabetes Res ; 2021: 8636050, 2021.
Article in English | MEDLINE | ID: mdl-34859105

ABSTRACT

BACKGROUND: Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. RESULTS: There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively. CONCLUSION: Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.


Subject(s)
Absorbable Implants , Acute Coronary Syndrome/therapy , Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Diabetes Mellitus , Drug-Eluting Stents , Non-ST Elevated Myocardial Infarction/therapy , Sirolimus/administration & dosage , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Aged , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/mortality , Cardiovascular Agents/adverse effects , Coronary Restenosis/etiology , Coronary Thrombosis/etiology , Diabetes Mellitus/diagnosis , Diabetes Mellitus/mortality , Female , Humans , Magnesium , Male , Middle Aged , Non-ST Elevated Myocardial Infarction/diagnosis , Non-ST Elevated Myocardial Infarction/mortality , Polymers , Prosthesis Design , Recurrence , Retrospective Studies , Risk Factors , Sirolimus/adverse effects , Time Factors , Treatment Outcome
10.
Pol Arch Intern Med ; 131(11)2021 11 30.
Article in English | MEDLINE | ID: mdl-34585554

ABSTRACT

Introduction: Optimal medical therapy (OMT) is the cornerstone of treatment for stable coronary disease with the ISCHEMIA trial showing similar outcomes using OMT with or without an initial invasive approach. Objectives: To describe OMT goal attainment in Polish ISCHEMIA participants compared with other countries. Patients and methods: Among 5179 trial participants, 333 were randomized in Poland. The median follow-up was 3.2 years. OMT targets were: not smoking, high-intensity statin therapy, low-density lipoprotein cholesterol (LDL-C) of less than 70 mg/dl, systolic blood pressure of less than 140 mm Hg, aspirin therapy, and ACEI / ARB, and ß-blocker therapy if indicated. Results: Compared with 36 other countries, at randomization, patients in Poland were older (67 [62­75] y vs 65 [58­71] y); P <⁠0.001), more often female (30% vs 22%; P = 0.002), with a longer history of angina (3 [1­9] y vs 1 [0­3] y; P <⁠0.001), and there were more cases of prior myocardial infarction (32% vs 18%; P <⁠0.01) and revascularization (PCI, 40% vs 19%; CABG, 11% vs 3%; P <⁠0.001 for both). The number of OMT goals attained increased from baseline to follow-up visits (5 [4­5] vs 6 [5­6]; P <⁠0.001) in Poland and other countries alike (P = 0.89 vs P = 0.14). In Poland, significant improvements were achieved regarding high-intensity statin therapy (27% vs 50%), LDL-C <⁠70 mg/dl (29% vs 65%), and systolic blood pressure of less than 140 mm Hg (63% vs 81%) (P <⁠0.001 for all), whereas not-smoking (89% vs 89%), aspirin (90% vs 88%), ACEI / ARB (93% vs 95%), and ß-blocker therapy (94% vs 90%) remained high. Conclusions: With regular surveillance and contemporary medical therapy, high OMT goal attainment was achievable among the participants of the ISCHEMIA trial in Poland relative to other countries. There is still room for improvement in LDL-C and blood pressure management.


Subject(s)
Coronary Artery Disease , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Myocardial Infarction , Percutaneous Coronary Intervention , Aged , Angiotensin Receptor Antagonists , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Aspirin , Cholesterol, LDL , Coronary Artery Disease/drug therapy , Female , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Male , Middle Aged , Poland , Treatment Outcome
11.
J Clin Med ; 10(17)2021 Aug 24.
Article in English | MEDLINE | ID: mdl-34501216

ABSTRACT

BACKGROUND: Despite the developments in percutaneous coronary interventions (PCI), women are still more likely than men to have unfavorable outcomes after PCI performed in Acute Coronary Syndrome (ACS). The mechanisms of this phenomena are not fully understood. Potential benefits of bioresorbable scaffolds (BRS) may be particularly expressed in the female population. Nevertheless, the data available currently are inconsistent and limited. This study evaluated the gender-related differences in the short-term clinical outcomes in ACS patients treated with implantation of two generations of BRS (first generation, Absorb; second generation, Magmaris). METHODS: The study was divided into two arms. To the first one, we qualified 160 patients with ACS treated with PCI who received 210 Absorb scaffolds. The second arm was composed of 193 patients with ACS who underwent PCI with Magmaris implantation. RESULTS: There were no significant sex-related differences in primary endpoints (cardiovascular-death, myocardial infarction, in-stent thrombosis) or principal secondary endpoints (of target-lesion failure, scaffold restenosis, death from any reason, other cardiovascular events) in either generation of BRS in a 1-year follow-up. CONCLUSIONS: Both genders tended to have a similar outcome in routine clinical practice following BRS implantation due to ACS. The magnesium bioresorbable scaffold (Magmaris) early outcome seemed to be more favorable in comparison to the Absorb scaffold.

12.
J Clin Med ; 10(14)2021 Jul 18.
Article in English | MEDLINE | ID: mdl-34300332

ABSTRACT

BACKGROUND: Diabetes mellitus (DM) is one of the major risk factors contributing to Acute Coronary Syndromes (ACS) and is associated with an increased risk of adverse clinical outcomes following percutaneous coronary intervention (PCI), even when the second generation of drug-eluting stents (DES) is used. In order to overcome the disadvantages of permanent caging of a vessel with metallic DES, bioresorbable scaffold (BRS) technology has been recently developed. However, the prognosis of patients with DM and ACS treated with PCI via subsequent implantation of Magmaris (Biotronik, Berlin, Germany)-a novel magnesium-bioresorbable scaffold-is poorly investigated. METHODS: A total of 193 consecutive subjects with non-ST elevation acute coronary syndrome (NSTE-ACS) who, from October 2016 to March 2020, received one or more Magmaris scaffolds were enrolled in this study. The diabetic group was compared with non-diabetic subjects. RESULTS: There were no significant differences in the occurrence of primary endpoints (cardiovascular death, myocardial infarction, and in-stent thrombosis) and principal secondary endpoints (target-lesion failure, scaffold restenosis, death from any reason, and other cardiovascular events) between the two compared groups in a 1-year follow-up period. CONCLUSIONS: The early 1-year-outcome of magnesium bioresorbable scaffold (Magmaris) seems to be favorable and suggests that this novel BRS is safe and effective in subjects with NSTE-ACS and co-existing DM.

14.
Kardiol Pol ; 79(7-8): 827-832, 2021.
Article in English | MEDLINE | ID: mdl-34125947

ABSTRACT

BACKGROUND: Research on the resorbable magnesium scaffolds (RMSs) has shown their safety and effectiveness in stable clinical conditions. It seems that this new therapeutic option could be promising for selected acute coronary syndrome (ACS) patients. AIMS: Our analysis aims to analyse the long-term performance of RMSs among ACS patients. METHODS: The study population consisted of consecutive ACS patients treated with the implantation of at least one RMS. The Magmaris ACS Registry was designed as a single-arm observational registry in the 'real-world' treatment practice setting. RESULTS: The study population consisted of 193 patients, predominantly male (78%), at a mean (SD) age of 64 (9) years and with the typical risk factors of ACS. Unstable angina (UA) was the indication for revascularisation in 32.1%, non-ST-segment myocardial infarction (NSTEMI) in 65.8% and ST-segment elevation myocardial infarction (STEMI) only in 2.1%. During the mean 24 months of follow-up, ten cases (5.2%) of target lesion failure (TLF) were diagnosed, of which five cases (2.6%) were clinically driven target lesion failure (CD-TLR), four cases (2.1%) of asymptomatic scaffold restenosis and one case (0.5%) of target vessel myocardial infarction (TV-MI). No cardiac deaths and 2 non-cardiac deaths (2.2%, both fatal strokes) were observed. No cases of scaffold thrombosis were observed during the median 24-month follow-up. CONCLUSIONS: The use of the RMSs in selected ACS patients is associated with procedural safety and promising early and long-term clinical efficacy and safety outcomes. Proper lesion selection is key to the long-term success of bioresorbable technology in this patient population.


Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Absorbable Implants , Acute Coronary Syndrome/surgery , Follow-Up Studies , Humans , Magnesium , Male , Middle Aged , Treatment Outcome
15.
Catheter Cardiovasc Interv ; 98(4): E540-E547, 2021 10.
Article in English | MEDLINE | ID: mdl-34051136

ABSTRACT

OBJECTIVE: We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions. BACKGROUND: The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods. METHODS: All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints. RESULTS: In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%. CONCLUSIONS: S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.


Subject(s)
Atherectomy, Coronary , Coronary Artery Disease , Lithotripsy , Vascular Calcification , Aged , Atherectomy, Coronary/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Feasibility Studies , Female , Humans , Lithotripsy/adverse effects , Male , Middle Aged , Treatment Outcome , Vascular Calcification/diagnostic imaging , Vascular Calcification/therapy
18.
Kardiol Pol ; 78(12): 1221-1226, 2020 12 23.
Article in English | MEDLINE | ID: mdl-33146499

ABSTRACT

BACKGROUND: A small number of female cardiologists work in the field of interventional cardiology. Such disparity is observed in most European countries. AIMS: We present the first national report on the practice patterns and outcomes regarding percutaneous coronary interventions (PCIs) performed by female operators (FOs) in Poland. METHODS: Data were collected from the National Registry of Invasive Cardiology Procedures (Ogólnopolski Rejestr Procedur Kardiologii Inwazyjnej [ORPKI]) between January 2014 and December 2017. RESULTS: A total of 31 FOs (4.1%) performed 12 935 PCIs (2.8%). The median (interquartile range [IQR]) number of PCIs performed by FOs per year was 75 (43-154), whereas that by male operators was 139 (67-216; P <0.01). Patients handled by FOs were characterized by a lower prevalence of cardiovascular risk factors and previous coronary artery interventions. Acute coronary syndrome was the main indication for treatment (74.66%). Compared with male operators, FOs handled significantly more patients with single­vessel disease (87.02% vs 84.72%; P <0.001). They used smaller contrast doses during PCIs (median [IQR], 170.36 [77.54] cm3 vs 173.48 [77.54] cm3; P <0.001) yet higher doses of radiation exposure (median [IQR], 843 [472-1409] mGy vs 815 [458-1390] mGy; P = 0.01). There was no difference in clinical outcomes (a composite of all­cause death, bleeding at the puncture site, or coronary artery perforation) associated with the operator's sex. CONCLUSIONS: Women represent a minority of operators in interventional cardiology and are responsible for a low percentage of PCIs. Nonetheless, the practice patterns and outcomes of PCIs performed by FOs are similar to those of male operators.


Subject(s)
Cardiology , Percutaneous Coronary Intervention , Europe , Female , Humans , Male , Poland/epidemiology , Registries
19.
Cardiol J ; 27(6): 677-684, 2020.
Article in English | MEDLINE | ID: mdl-30761516

ABSTRACT

BACKGROUND: The PSP (predilatation, sizing, post-dilatation)-technique was developed to improve the prognosis of patients after bioresorbable vascular scaffold (BVS) implantation. In acute coronary syndrome (ACS) the use of BVS is particularly demanding and carries some potential risk regarding aggressive lesion preparation, proper vessel sizing due to spasm and thrombus inside the artery. The aim herein, was to determine the long-term results of BVS stenting in ACS patients depending on the scaffold implantation technique. METHODS: The present study is a prospective, two-center study, which consisted of 182 patients who underwent percutaneous coronary intervention (PCI) with BVS (Absorb, Abbott Vascular, Santa Clara, California, USA) implantation for the ACS. All patients were divided into two groups. The first consisted of 52 patients treated with the PSP-technique (PSP group). The second group enrolled 130 patients treated with a non-PSP procedure (non-PSP group). RESULTS: The procedure was successful in all patients. The mean observation time was 28.8 ± 16.5 months (median 28.3 months, interquartile range 24.0 [17.0-41.0] months). It was found that target vessel failure (TVF) was consistently reduced in patients using the PSP-technique as compared with the non-PSP group (5.8% vs. 17.7%, p = 0.03). Moreover, PSP-technique was superior to non-PSP-technique concerning major adverse cardiac events (MACE) (3.7% vs. 22.3%, p = 0.02). Logistic regression analysis revealed that the use of PSP technique significantly decreased the risk of target vessel revascularization (odds ratio [OR] 0.11, p = 0.01), TVF (OR 0.28, p = 0.03) and MACE (OR 0.29, p = 0.02). CONCLUSIONS: The PSP-technique for BVS implantation improves long-term results and should also be recommended for newer generations of the bioresorbable scaffold.


Subject(s)
Acute Coronary Syndrome , Coronary Artery Disease , Percutaneous Coronary Intervention , Absorbable Implants , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/surgery , Humans , Prospective Studies , Prosthesis Design , Treatment Outcome
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